Clinical Trial Details

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Quizartinib With Standard of Care Chemotherapy and as Maintenance Therapy in Patients With Newly Diagnosed FLT3-ITD (+) AML

Official Title

A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib (AC220) Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Maintenance Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Principal Investigator

Larson, Richard

Brief Summary

This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of
this study is to compare the effect of quizartinib versus placebo (administered with
standard induction and consolidation chemotherapy, then administered as maintenance therapy
for up to 12 cycles) on event-free survival in subjects with FLT3-ITD positive AML.